NCT06620120

Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease

Single-centre, Prospective, Randomised, Controlled, Study to Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles by Millet Innovation on the Symptoms and Quality of Life of Patients With Chronic Venous Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Millet Innovation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to evaluate the effect of wearing the insoles developed by Millet Innovation on the symptoms and quality of life of patients suffering from chronic venous disease.

Conditions

• Venous Disease
• Quality of Life
• Symptoms and Signs

Interventions

Type	Name	Description
DEVICE	Insoles	At the D0 visit, if the patient is assigned to the arm with insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm.
OTHER	Without insoles	At the D0 visit, if the patient is assigned to the arm without insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-02-11
• Completion: 2024-03-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: France